openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
These labels are deterministic app interpretations, not FDA categories.
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
Code information
UDI 10885862093202 Serial Numbers: T31634510, T31788559
Distribution pattern
OK, VA, FL
device · product 2 of 3
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
These labels are deterministic app interpretations, not FDA categories.
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
Code information
UDI 10885862093219 Serial Numbers: T32309666, T32309672
Distribution pattern
OK, VA, FL
device · product 3 of 3
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
These labels are deterministic app interpretations, not FDA categories.
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
Code information
UDI 10885862094100 Serial Numbers: T31977961, T31977962, T31977968
